Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001214820
Ethics application status
Approved
Date submitted
4/07/2021
Date registered
10/09/2021
Date last updated
20/07/2023
Date data sharing statement initially provided
10/09/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Validation of the Paediatric Appendicitis Risk Calculator in the South Australian Emergency Department Setting
Scientific title
Validation of the Paediatric Appendicitis Risk Calculator in the South Australian Emergency Department Setting for 5 to 18 year olds presenting with abdominal pain
Secondary ID [1] 304455 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Abdominal Pain 322277 0
Appendicitis 322278 0
Condition category
Condition code
Emergency medicine 319960 319960 0 0
Other emergency care
Oral and Gastrointestinal 319961 319961 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Prospectively collect data and validate if the Paediatric Appendicitis Risk Calculator (pARC) score is useful in determining the risk of appendicitis in an Australian setting.

Parameters observed include symptoms of the patient's abdominal pain including the duration of pain, location of pain, and migration of pain to right side. Clinical signs are assessed, these include guarding, percussion/cough/rebound tenderness, pain with walking and right lower quadrant tenderness. Presence of anorexia, nausea, vomiting and the patient's temperature are also recorded.
Results of bedside ultrasound, formal ultrasound, blood sampling results and if an operation is performed, the histology report are also collected.
The clinician's suspicion of appendicitis is also recorded.

There is no active participation for the participants. This is purely an observational study and there is no change in management. If blood tests are taken as clinically necessary, they are recorded.
The observation period for each patient is their initial presentation to the emergency department and they will either be followed up as they have undergone an operation and appendicitis is confirmed, or they will be discharged and followed up via a text message within 2 - 3 weeks of their initial presentation to ensure there are no appendicitis diagnosis' which are missed.

The total duration of the observation is all ED presentations at the Women's and Children's Hospital for abdominal pain where appendicitis is a differential, over the next 18 months.
Intervention code [1] 320800 0
Early Detection / Screening
Comparator / control treatment
The pARC score will be compared to existing scores including the Paediatric appendicitis score and Alvarado score, and modified versions of these scores.
The Paediatric appendicitis score and Alvarado score are validated scores to assess the risk of appendicitis in the paediatric population, however they use a much more crude method of assessing risk. They incorporate very similar parameters to the pARC however use a score system to identify low, intermediate and high risk of appendicitis.
The pARC uses a complex formula to calculate the specific risk of appendicitis using the collected parameters.

The modified versions of the PAS and Alvarado score are similar score systems however they can be calculated without any blood sampling investigations, which will be utilised in those patients who did not have any blood tests.
Control group
Active

Outcomes
Primary outcome [1] 327834 0
pARC score correlation with the histopathological diagnosis of appendicitis (confirmed within 7-14 days of presentation)
This data will be sourced from review of medical records
Timepoint [1] 327834 0
Assessed 18 months after the initiation of study enrolment
Secondary outcome [1] 396719 0
Comparison of the pARC score to the modified Alvarado score (which do not include investigations)
No blood or imaging results are included in the modified Alvarado score; this only includes the clinical parameters outlined in the Alvarado score
This data will be sourced from review of medical records
Timepoint [1] 396719 0
Assessed 18 months after initiation of study enrolment
Secondary outcome [2] 398642 0
Comparison of the pARC score to the Paediatric Appendicitis Score (PAS). Data will be sourced from data collection sheets in the emergency department, as well as review of medical records.
Timepoint [2] 398642 0
Assessed 18 months after initiation of study enrolment
Secondary outcome [3] 398643 0
Comparison of the pARC score to the Alvarado Score. Data will be sourced from data collection sheets in the emergency department, as well as review of medical records.
Timepoint [3] 398643 0
Assessed 18 months after initiation of study enrolment
Secondary outcome [4] 398644 0
Comparison of the pARC score to the modified PAS (which do not include investigations). No blood or imaging results are included in the modified PAS; this only includes the clinical parameters outlined in the PAS. This data will be sourced from review of medical records
Timepoint [4] 398644 0
Assessed 18 months after initiation of study enrolment
Secondary outcome [5] 400137 0
Sensitivity of the pARC score. Data will be sourced from data collection sheets in the emergency department, as well as review of medical records. Sensitivity will be determined by comparing the pARC score (low, medium and high risk) to the outcome of positive appendicitis as determined histologically.
Timepoint [5] 400137 0
18 months
Secondary outcome [6] 400838 0
Specificity of the pARC score. Data will be sourced from data collection sheets in the emergency department, as well as review of medical records. Specificity will be determined by comparing the pARC score (low, medium and high risk) to the outcome of positive appendicitis as determined histologically.
Timepoint [6] 400838 0
18 months

Eligibility
Key inclusion criteria
Children 5yo to 18yo
Abdominal pain – generalised or right sided
<5 days duration (120 hours)
Initial presentation with abdominal pain
Where appendicitis is a differential diagnosis
Patients with significant co-morbidities can be included however noted that they may have confounders. (eg. autism, type 1 diabetes, type 2 diabetes, thyroid disease, congenital cardiac disease)
Minimum age
5 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Testicular pain
Pain >120 hours duration
Previous appendicectomy
Previous bowel surgery, IBD, chronic pancreatitis, CF, sickle cell disease
Medical condition preventing ability to obtain accurate history – eg non verbal
Transplant patients
Abdominal trauma within 2 weeks
Pregnant
Appendicitis identified prior to initial presentation to hospital

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
From the paper by Kharbanda et al. 2018 the observed rate of having appendicitis can be obtained for each pARC category. Using a Fisher’s Exact Conditional Test for Two Proportions, the proportion of those having appendicitis in the Low pARC category (0.10) is compared to the proportion of having appendicitis in the High pARC category (0.97), with power 80% and alpha=0.05, for a 2-sided test. The sample size per group required is 7, for 7 categories giving a total of N=49. However, the difference between Intermediate pARC (0.78) and High pARC (0.97) may also be of interest. Using a similar calculation, the sample size required per group is 52 for 7 categories giving a total of N=364. To adjust for 25% loss to follow up (missing blood tests) the total sample size required (for the Intermediate vs High comparison) is N=364*(100/75) = 486 participants.

Also from the Kharbanda paper , Area under the curve for PAS is 0.77 and for Area under curve for pARC is 0.85. Using Sample Size Comparison of ROC curves (https://www.medcalc.org/manual/sample-size-ROC-AUC.php), with correlation=0 for both PAS and pARC (the most conservative correlation), ratio of PAS to pARC being 1 (from the same participants), Type 1 error=0.05, and Type 2 error=0.20 (80% power), it was calculated that N=257 participants are required. To adjust for 25% loss to follow up (missing blood tests) the total sample size required is N=257*(100/75) = 343 participants.


Also from the paper by Kharbanda et al. 2018, sensitivity for pARC categories is up to 100% and specificity up to 72.5% for pARC<50%. From the paper Goldman et al. 2008 sensitivity for PAS is 42% and specificity is 50%. From the paper Peyvasteh et al. 2017 sensitivity for MAS is 91.3% and specificity is 38.4%. Using a Fisher’s Exact Conditional Test for Two Proportions, the scoring system closest to pARC for sensitivity and specificity are compared to pARC, with power 80% and alpha=0.05, for a 2-sided test. For sensitivity, the sample size per group required is 130, for 3 scores giving a total of N=390. For specificity, the sample size per group required is 81, for 3 scores giving a total of N=243. To adjust for 25% loss to follow up (missing blood tests) for sensitivity, the total sample size required is N=390*(100/75) = 520 participants.

Overall the required total sample size required to obtain adequate power for all analyses mentioned above is N=520.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
31/05/2021
Date of last participant enrolment
Anticipated
17/12/2022
Actual
1/08/2022
Date of last data collection
Anticipated
31/12/2022
Actual
1/09/2022
Sample size
Target
520
Accrual to date
Final
650
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 19704 0
Womens and Childrens Hospital - North Adelaide
Recruitment postcode(s) [1] 34339 0
5006 - North Adelaide

Funding & Sponsors
Funding source category [1] 308815 0
Hospital
Name [1] 308815 0
Women's and Children's Hospital
Country [1] 308815 0
Australia
Primary sponsor type
Individual
Name
Alexander Howes
Address
Women's and Children's Hospital
72 King William Road North Adelaide
South Australia 5006
Country
Australia
Secondary sponsor category [1] 310004 0
None
Name [1] 310004 0
nil
Address [1] 310004 0
nil
Country [1] 310004 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308728 0
Women's and Children's Health Network Ethics Committee
Ethics committee address [1] 308728 0
Ethics committee country [1] 308728 0
Australia
Date submitted for ethics approval [1] 308728 0
Approval date [1] 308728 0
10/02/2021
Ethics approval number [1] 308728 0
2020/HRE01716 (HREC/20/WCHN/152

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111686 0
Dr Alexander Howes
Address 111686 0
Women's and Children's Hospital
72 King William Road North Adelaide
South Australia 5006
Country 111686 0
Australia
Phone 111686 0
+61 08 8161 6651
Fax 111686 0
Email 111686 0
[email protected]
Contact person for public queries
Name 111687 0
Alexander Howes
Address 111687 0
Women's and Children's Hospital
72 King William Road North Adelaide
South Australia 5006
Country 111687 0
Australia
Phone 111687 0
+61 08 8161 6651
Fax 111687 0
Email 111687 0
[email protected]
Contact person for scientific queries
Name 111688 0
Alexander Howes
Address 111688 0
Women's and Children's Hospital
72 King William Road North Adelaide
South Australia 5006
Country 111688 0
Australia
Phone 111688 0
+61 08 8161 6651
Fax 111688 0
Email 111688 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is undecided and we may decide to share later, but currently this information will not be available to the public


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.